STATES
NEED TO DO BETTER JOB
OF REGULATING OUTPATIENT CARE,PARTICULARLY
IN SITES THAT PERFORM SURGERY

Analysis Reveals Serious Oversight Gaps That Put Patients At Risk

Washington D.C.
- To protect patients and improve quality, a new report warns that states need
to do a significantly better job of regulating care rendered in outpatient settings,
particularly in physician offices that perform surgery. Today's regulatory system
for outpatient sites "is badly fragmented," offering very little insight
into the extent or nature of adverse medical events in these settings, say authors
writing in the July/August issue of the journal Health Affairs. Mandatory
accreditation, combined with programs designed to ensure the safe provision
of anesthesia, would do a lot to boost the quality of care in the outpatient
setting and avert medical errors, the authors conclude.

Elizabeth Lapetina, a research
analyst with the Lewin Group, who co-wrote the article as an undergraduate at
Princeton University and Elizabeth Armstrong, an assistant professor of sociology
and public affairs at Princeton University, reviewed what is known about the
incidence and nature of medical errors occurring in physician offices, ambulatory
care facilities, and surgicenters. Their assessment of the outpatient environment
comes amid heightened public concern about the volume of medical errors in health
care, and a dramatic growth in the number and scope of outpatient procedures.

Today, nearly two thirds
of all surgical procedures are performed in the outpatient setting. The number
of outpatient surgical procedures performed has ballooned from 400,000 in 1984
to 8.3 million in 2000. Thanks to improved technology and lower costs, the number
of procedures being performed in office settings is skyrocketing, the authors
report, particularly surgical procedures. They note that between 1992 and 1999,
office-based liposuction procedures increased 389 percent; breast augmentation
procedures, 413 percent; and eyelid surgery, 139 percent. This year alone, the
authors estimate, some 10 to 20 percent of all elective surgeries will be performed
in 41,000 office-based surgical facilities.

"While reducing the
number of medical errors and improving patient safety have become major issues
in health policy, errors occurring in the outpatient setting have not received
enough attention and current regulations do not adequately protect patients,"
says Lapetina. Today, 20 states require ambulatory surgical facilities to be
accredited by an approved accrediting organization such as the Joint Commission
on Accreditation of Healthcare Organizations or the Accreditation Association
for Ambulatory Health Care. But only 10 states have placed any regulations on
office-based procedures, and only a handful of states have reporting systems
for outpatient settings in general.

When it comes to standards
for surgery or anesthesia in the outpatient setting, most states have no regulations,
according to the article. New Jersey and Mississippi are the only states that
mandate the reporting of adverse events that occur in physician's offices, according
to their analysis. The authors say there is a "pressing need" for
all states to address safety in outpatient sites and to ensure that only qualified
providers perform surgical procedures in their offices.

Cosmetic surgery is raising
the most concerns. As techniques improve, "an alarming number of physicians
with minimal training have developed office-based practices to perform these
procedures," the authors warn, noting that it's offered by physicians who
sometimes merely attend a weekend seminar or watch a short training video. Nearly
half of the 250,000 liposuctions performed in 1997 were performed by practitioners
other than plastic surgeons. Because only two states require reporting of adverse
events occurring in physician's offices, it is unclear how many complications
from these procedures occur nationally, the authors say However, a review of
existing studies indicate that the death rate from office-based liposuction
is higher than the death rate from car crashes, according to the authors.

Regulating procedural/practice
standards for office-based physicians is difficult, the researchers say. While
hospitals and ambulatory surgical centers are regulated by each state's department
of health, physicians and their private offices are regulated by the state's
board of medical examiners and are not subject to the same scrutiny. Three states
(FL, NJ, NY) have attempted to establish practice standards to reduce outpatient
medical errors, either through regulations or legislation. Of the three, New
Jersey has gone the farthest.

The state has implemented
standards for outpatient surgical centers that are similar to hospitals. New
Jersey's standards address patient monitoring during procedures, technology
implementation, and equipment purchase and maintenance. General anesthesia can
only be administered by an anesthesiologist or nurse anesthetist working under
the supervision of an anesthesiologist. To practice in an office, an anesthesiologist
must have admitting privileges at a nearby hospital. The state also has created
a mandatory reporting system, requiring physicians to report any deaths, complications,
or adverse events that occur during office-based procedures.

The authors conclude that
states need to take stronger steps to improve patient safety in the outpatient
setting, including requiring accreditation of outpatient facilities and setting
standards to minimize unnecessary complications from anesthesia. For example,
they say, states could mandate the use of a licensed anesthesiologist when major
liposuction procedures are performed in office settings. Finally, they urge
that the federal Department of Health & Human Services mandate that all
states create standards of care for office-based surgery and procedures involving
anesthesia as soon as possible.

Health Affairs, published
by Project HOPE, is a bimonthly multidisciplinary journal devoted to publishing
the leading edge in health policy thought and research. Copies of the July/August
2002 issue will be provided free to interested members of the press. Address
inquiries to Jon Gardner at Health Affairs at 301-656-7401, ext. 230
or via e-mail, press@healthaffairs.org.
Selected articles from the July/August issue are available free on the journal's
Web site, www.healthaffairs.org.